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Primatene Mist CRL Underscores Challenges For OTC Asthma Treatments

 
• By Malcolm Spicer

Second FDA complete response letter for a reformulated Primatene Mist likely pushes back by another 18 months Amphastar's potential relaunch of the OTC product after satisfying the US agency's concerns about consumers correcting using the product without a doctor’s intervention.

Amphastar Pharmaceuticals Inc. keeps its eye on the goal of making its asthma inhaler Primatene Mist available OTC again as a second complete response letter from FDA pushes the finish line back further.

Amphastar on Dec. 27 announced it received a CRL on the firm’s new drug application for making Primatene Mist available reformulated with the original active ingredient, epinephrine, but with hydrofluoroalkane replacing ozone-depleting chlorofluorocarbons as a propellant

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